Ability and acceptability of children (2-7 years) to swallow mini-tablets
Conditions
Interventions
Group 1: Administration of 16 placebo mini-tablets with soft food
Group 2: Administration of 32 placebo mini-tablets with soft food
Group 3: Administration of 16 placebo mini-tablets with water
Group
Sponsors
Actelion Pharmaceuticals Ltd.
Eligibility
Sex/Gender
All
Age
2 Years to 7 Years
Inclusion criteria
Inclusion criteria: - Children (boys and girls) between =2 to <7 years of age. - Based on the assessment of medical history and physical examination (ears, nose, mouth, and throat, respiratory, and gastrointestinal [abdomen]) patients must be able to follow the study procedures. - Both parents or their LAR must sign an informed consent indicating that they understand the purpose of, and examination procedures required for, participant obligations as well as risks and benefits of participation in the study and is willing to allow the child to participate in the study and likely to comply with examination procedures and restrictions. In case only one parent is present at site to give consent, consent of the second parent may be documented by an independent witness with approval via phone/email/fax. Consent by one parent is acceptable in case of documented sole custody.
Exclusion criteria
Exclusion criteria: - Any impairment of swallowing mini-tablets as a consequence of : chronic illness (eg, cerebral palsy), acute illness (eg, sepsis, respiratory distress, gastroenteritis, respiratory tract infection), or oral deformation (eg, congenital abnormality, injury, allergy, infection, and surgery). - Known allergies, hypersensitivity, or intolerance to any amount of the excipients of placebo mini-tablets. - Children, who have eaten one hour before examination and who afterwards feel sick. - After surgical intervention, where the child is not allowed to drink and is not capable to follow the study-related instructions. - Use of any drug that causes nausea, fatigue, or palsy per local prescribing information. - Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator. - Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the acceptability of a single administration of 16 placebo mini tablets administered with soft food in children aged between =2 to <7 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the acceptability of a single administration of 32 mini tablets administered with soft food in children aged between =2 to <7 years in comparison to administration with water. To investigate the swallowability of a single administration of 16 mini-tablets administered with soft food in children aged between =2 to <7 years in comparison to administration with water. To investigate the swallowability of a single administration of 32 mini-tablets administered with soft food in children aged between =2 to <7 years in comparison to administration with water. To assess the acceptability, swallowability, and palatability of a single administration of 16 and 32 mini-tablets administered with soft food in subsets of children divided into different age groups: 2 to <3 years, 3 to <4 years, 4 to <5 years, 5 to <6 years, and 6 to <7 years. | — |
Countries
Germany
Contacts
Public ContactSimon Grill
Janssen R&D
Outcome results
None listed